EP2475376A4 - FORMULATIONS FOR LYSOSOMAL ENZYMES - Google Patents

FORMULATIONS FOR LYSOSOMAL ENZYMES

Info

Publication number
EP2475376A4
EP2475376A4 EP10790224.9A EP10790224A EP2475376A4 EP 2475376 A4 EP2475376 A4 EP 2475376A4 EP 10790224 A EP10790224 A EP 10790224A EP 2475376 A4 EP2475376 A4 EP 2475376A4
Authority
EP
European Patent Office
Prior art keywords
formulations
lysosomal enzymes
lysosomal
enzymes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP10790224.9A
Other languages
German (de)
French (fr)
Other versions
EP2475376A2 (en
EP2475376B1 (en
Inventor
Jonathan H Lebowitz
Byeong Chang
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biomarin Pharmaceutical Inc
Original Assignee
Biomarin Pharmaceutical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biomarin Pharmaceutical Inc filed Critical Biomarin Pharmaceutical Inc
Priority to EP16153694.1A priority Critical patent/EP3075386B1/en
Priority to EP19203438.7A priority patent/EP3679942A1/en
Publication of EP2475376A2 publication Critical patent/EP2475376A2/en
Publication of EP2475376A4 publication Critical patent/EP2475376A4/en
Application granted granted Critical
Publication of EP2475376B1 publication Critical patent/EP2475376B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/30—Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Obesity (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP10790224.9A 2009-06-17 2010-06-17 Formulations for lysosomal enzymes Active EP2475376B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP16153694.1A EP3075386B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP19203438.7A EP3679942A1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18774709P 2009-06-17 2009-06-17
PCT/US2010/039083 WO2010148253A2 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes

Related Child Applications (3)

Application Number Title Priority Date Filing Date
EP16153694.1A Division-Into EP3075386B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP16153694.1A Division EP3075386B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP19203438.7A Division EP3679942A1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes

Publications (3)

Publication Number Publication Date
EP2475376A2 EP2475376A2 (en) 2012-07-18
EP2475376A4 true EP2475376A4 (en) 2013-05-22
EP2475376B1 EP2475376B1 (en) 2016-03-30

Family

ID=43357058

Family Applications (3)

Application Number Title Priority Date Filing Date
EP16153694.1A Active EP3075386B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP19203438.7A Pending EP3679942A1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP10790224.9A Active EP2475376B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP16153694.1A Active EP3075386B1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes
EP19203438.7A Pending EP3679942A1 (en) 2009-06-17 2010-06-17 Formulations for lysosomal enzymes

Country Status (4)

Country Link
US (1) US8785168B2 (en)
EP (3) EP3075386B1 (en)
ES (2) ES2758827T3 (en)
WO (1) WO2010148253A2 (en)

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US20140377244A1 (en) 2011-12-23 2014-12-25 Shire Human Genetic Therapies, Inc. Stable formulations for cns delivery of arylsulfatase a
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ES2679374T3 (en) 2012-11-27 2018-08-24 Biomarin Pharmaceutical Inc. Targeted therapeutic lysosomal enzyme fusion proteins and uses thereof
JP2016514096A (en) 2013-02-20 2016-05-19 バレリオン セラピューティクス, エルエルシー Methods and compositions for the treatment of Pompe disease
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US10709700B2 (en) 2014-09-15 2020-07-14 Orphazyme A/S Arimoclomol formulation
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IL299470B2 (en) 2015-12-30 2026-05-01 Amicus Therapeutics Inc Augmented acid alpha-glucosidase for the treatment of pompe disease
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EP2475376B1 (en) 2016-03-30
US20120148556A1 (en) 2012-06-14
EP3679942A1 (en) 2020-07-15
WO2010148253A3 (en) 2011-05-26
ES2758827T3 (en) 2020-05-06
ES2569514T3 (en) 2016-05-11
EP3075386A1 (en) 2016-10-05
EP3075386B1 (en) 2019-10-16
WO2010148253A2 (en) 2010-12-23
US8785168B2 (en) 2014-07-22

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